DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-20 is/are pending.
Allowable Subject Matter
Claim(s) 13-19 are allowable over the prior art and would be allowable if the non-prior art rejections noted below are addressed.
Claim(s) 13-19 are allowable over the prior art because the prior art lacks a specific relative orientation of the flat meridian in relationship to the midline, which in turn is specifically oriented relative to the haptics/their fluid channels.
Information Disclosure Statement
The information disclosure statement filed 5/23/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the line through citation, FOR #7, was not provided. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
All non-lined through citations were considered.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 recites “the least”, which should be “least”.
Claim 10 recites “the greatest”, which should be “greatest”.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,744,697. Although the claims at issue are not identical, they are not patentably distinct from each other because the following prior claims contain the limitations claimed by the current Application as indicated in the following table.
Current Application
Prior Patent ‘697
1, 20
1, 9, 15
2
1
3
2
4
3
5
4
6
15
7
5
8
6
9
7
10-11
1
12
8
13
1
14
9
15
5, 12, 16
16
13
17
14
18
19
19
9
With respect to prior claim 9, the Examiner notes the channels require a closed end and the connection to the lens allowing the fluid to flow between the haptic and the lens chamber during accommodation meets the claimed haptic structure.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5 and 7-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Argento, et al (Argento) (US 2018/0177589 A1).
Regarding Claim 1, Argento teaches a toric accommodating intraocular lens (e.g. abstract, [0013], [0507]) , comprising:
an optic portion (e.g. Figures 13A-F, annotated Figure 13C below) comprising an anterior element (e.g. annotated Figure 13C below, #1330) having an anterior optical surface (surface of #1330), a posterior element (e.g. annotated Figure 13C below; optic portion below, as shown, the dashed line) having a posterior optical surface (e.g. Figure 13D, surface of #1310), and
a fluid-filled optic fluid chamber defined therebetween (e.g. annotated Figure 13C below, chamber between the anterior and posterior elements), wherein the anterior optical surface is shaped such that a radius of curvature of the anterior optical surface differs along different optical surface meridians (e.g. [0366], [0507], [0014], lens #1330 is toric; toric lenses inherently have a steep meridian (lesser radius of curvature) and a flat meridian (greater radius of curvature)).
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Annotated Figure 13C, Argento
Regarding Claim 2, the anterior optical surface is shaped such that the radius of curvature of the anterior optical surface differs along different optical surface meridians of the anterior optical surface (e.g. [0366], [0507], [0014], lens #1330 is toric and thus inherently has steep and flat meridians).
Regarding Claim 3, the radius of curvature of the anterior optical surface varies periodically around the anterior optical surface (e.g. [0366], [0507], [0014], lens #1330 is toric and thus inherently has steep and flat meridians that are perpendicular to each other, where a period is 90o).
Regarding Claim 4, the anterior element further comprises an anterior inner surface that is rotationally symmetric (e.g. annotated Figure 13C(2) below; here, the anterior and posterior elements are considered those noted supra for claim 1 plus any portions of each element that extends beyond the dashed line at the radially outermost edge; e.g. [0042], the portions of the element radially between each set of the dotted lines is rotationally symmetric, including the inner surface of the anterior element).
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Annotated Figure 13C(2), Argento
Regarding Claim 5, the anterior element has an anterior element thickness as measured from the anterior optical surface to the anterior inner surface (e.g. Figure 13C), wherein the anterior element thickness varies periodically around the anterior element (discussed supra for claim 1; toric lenses inherently have this variability).
Regarding Claim 7, a base power of the optic portion is configured to change based on a pressure within the fluid-filled optic fluid chamber (the optic portion includes a fluid chamber and is an accommodating IOL, discussed supra for claim 1, therefore, as accommodation occurs the pressure in the chamber changes causing the accommodative changes in the overall optical portion thereby changing the power of the optical portion, which changes the base power based on changes in fluid pressure).
Regarding Claim 8, a cylinder power of the optic portion is configured to remain substantially unchanged throughout the change in base power of the optic portion in response to changes in the pressure within the fluid-filled optic fluid chamber (e.g. [0011], the base power of the fixed lens within the optical portion remains substantially unchanged, while the overall optical portion changes).
Regarding Claim 9, wherein a cylinder orientation of the optic portion is configured to remain substantially unchanged throughout the change in base power of the optic portion in response to changes in the pressure within the fluid-filled optic fluid chamber (e.g. [0011], the base power of the fixed lens within the optical portion remains substantially unchanged, while the overall optical portion changes).
Regarding Claim 10, the anterior optical surface comprises a flat meridian and a steep meridian oriented substantially perpendicular to the flat meridian, and wherein the radius of curvature is the least along the steep meridian and the radius of curvature is the greatest along the flat meridian (discussed supra for claim 1).
Regarding Claim 11, the flat meridian is oriented at an oblique angle with respect to the midline substantially bisecting the optic portion (since the optic portion is circular, there is inherently a midline bisecting it that is also at an oblique angle to the flat meridian).
Regarding Claim 12, the oblique angle is a clockwise rotational angle between about 30 degrees and 60 degrees (there is inherently a midline bisecting the optical portion that is also about 30 to 60 degrees from the flat meridian).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argento, et al (Argento) (US 2018/0177589 A1) in view of Argal, et al (Argal) (US 2016/0058552).
Regarding Claim 6, Argento discloses the invention substantially as claimed but fails to teach the posterior optical surface is an aspherical surface.
Argal teaches a fixed lens with a toric surface and an aspheric surface opposite the toric surface (e.g. [0089]).
Argal and Argento are concerned with the same field of endeavor as the claimed invention, namely IOLs having toric surfaces.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Argento’s fixed lens such that the side of the lens opposing the toric lens is aspheric (here, the posterior optical surface) as taught by Argal in order to correct or mitigate corneal astigmatism and presbyopia (e.g. Argal, [0088]).
Regarding Claim 20, Argento teaches a toric accommodating intraocular lens (discussed supra for claim 1), comprising:
an optic portion (discussed supra for claim 1) comprising a posterior element (e.g. annotated Figure 13C above; optic portion above, as shown, the dashed line) having a posterior optical surface (e.g. Figure 13D, surface of #1330), wherein the posterior optical surface is shaped such that a radius of curvature of the posterior optical surface differs along different optical surface meridians (e.g. [0366], [0507], [0014], lens #1330 is toric and thus inherently has a steep meridian (lesser radius of curvature) and a flat meridian (greater radius of curvature)), and wherein the posterior element has a posterior element thickness as measured from the posterior optical surface to the posterior inner surface (e.g. Figure 13C), wherein the posterior element thickness varies periodically around the posterior element (toric lenses as discussed supra; toric lenses inherently have this variability).
Argento discloses the invention substantially as claimed but fails to teach the posterior element further comprises a posterior inner surface that is rotationally symmetric.
Argal teaches a fixed lens with a toric surface and an aspheric surface opposite the toric surface (e.g. [0089]).
Argal and Argento are concerned with the same field of endeavor as the claimed invention, namely IOLs having toric surfaces.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Argento’s fixed lens such that the side of the lens opposing the toric lens is aspheric (here, the posterior inner surface) as taught by Argal in order to correct or mitigate corneal astigmatism and presbyopia (e.g. Argal, [0088]).
The Examiner notes aspheric lenses are inherently rotationally symmetric.
Relevant Prior Art
US 5,203,788 to Wiley teaches an accommodating fluid lens having multiple meridians (e.g. abstract, column 8, lines 28-46).
US 2016/0220350 A1 to Gerlach teaches the details of a toric surface (e.g. abstract, [0052], [0126]-[0128]).
US 2019/0091008 A1 to Ishikawa teaches the details of a toric intraocular lens (e.g. abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 3/20/2026
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